+ All Categories
Home > Documents > Teach-in Presentation November 6,...

Teach-in Presentation November 6,...

Date post: 29-Sep-2020
Category:
Upload: others
View: 1 times
Download: 0 times
Share this document with a friend
23
Teach-in Presentation November 6, 2013 OTCQB: BTHE www.bostonti.com Diabetes
Transcript
Page 1: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

Teach-in Presentation

November 6, 2013

OTCQB: BTHE

www.bostonti.com

Diabetes

Page 2: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

Safe Harbor

2

This presentation contains "forward-looking statements" within the meaning of the

“safe-harbor” provisions of the private securities litigation reform act of 1995.

Such statements involve known and unknown risks, uncertainties and other

factors that could cause the actual results of the Company to differ materially from

the results expressed or implied by such statements, including changes from

anticipated levels of revenues, future national or regional economic and

competitive conditions, difficulties in developing the Company’s technology

platforms, retaining and expanding the Company’s customer base, fluctuations in

consumer spending on the Company’s products and other factors. Accordingly,

although the Company believes that the expectations reflected in such forward-

looking statements are reasonable, there can be no assurance that such

expectations will prove to be correct. The Company has no obligation to update

the forward-looking information contained in this presentation.

Page 3: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

Company Mission

Boston Therapeutics’ goal is to be a leading

developer of novel compounds based on

complex carbohydrate chemistry for the

treatment of diabetes.

3

Page 4: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

Key Highlights

• PAZ320 uniquely positioned to capture market share of $35B* diabetes

drug market: Phase 2a clinical trial completed; Enrolling Phase 2b

• IP portfolio places the Company ahead of the curve in carbohydrate

drug development

• Team with extensive expertise in regulatory and clinical development,

with multiple submissions and approvals to the FDA

• Raised $5.8 million in 2013 to support product portfolio near-term

clinical requirements

• Submitted request to FDA for Pre-IND meeting to conduct Phase 3

study

4

Page 5: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

Complex Carbohydrate Chemistry Platform

• Growing interest in carbohydrates in drug design

– Plays fundamental role in normal cell functions

– Participates in cell-cell interactions

• David Platt, Ph.D. is an expert and pioneer in

the use of galactomannan in drug design

– Holder of more than ten patents

• Co-editor of Carbohydrate Drug Design

– Influential volume in the design of drugs using complex carbohydrates

• Founder & CEO of three publicly traded companies:

– International Gene Group / SafeScience (Nasdaq:SAFS) : Cancer

– Pro-Pharmaceuticals now Galectin Therapeutics (Nasdaq: GALT) - Liver /cancer

– Boston Therapeutics (OTCQB: BTHE) - Diabetes

5

Page 6: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

Experienced Management Team

6

Team Background

David Platt ,Ph.D.

Chief Executive Officer

Chief Financial Officer

Chairman of the Board

• 2001-2009: CEO/Chairman of Pro-Pharmaceuticals, now Galectin Therapeutics (NASDAQ: GALT)

• 1995-2000: CEO, Chairman and founder of SafeScience Inc., a Nasdaq-listed company

• 1992-1995: CEO, Chairman and founder of Int’l Gene Group, the predecessor to SafeScience, Inc.

• 1989-1991: Research fellow at the Michigan Foundation (now Barbara Ann Karmanos Institute)

• Research fellow at the Weizmann Institute of Science, Rehovot, Israel

• Ph.D. in Chemistry in 1988 from Hebrew University in Jerusalem

• Published peer-reviewed articles and holds many patents, primarily in the field of carbohydrate chemistry

Kenneth A. Tassey, Jr.

President , Director

• Co-founder and President of Boston Therapeutics, Inc. since November 2010

• CEO & President of Boston Therapeutics from 2009 until merger with Avanyx Therapeutics

• Former President of TKCI (consulting firm for commercial finance) from 2007 to 2009

Anthony Squeglia

VP, Strategic Planning

• Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor company Pro-

Pharmaceuticals, Inc. (Amex: PRW) from 2007 to 2012

• VP Investor Relations for Pro-Pharmaceuticals from 2003 to 2007

• Senior management positions at AT&T, ITT, Unisys, Summa Four, Quentra Networks and Colonial Penn

• BBA from Wharton, MBA from Pepperdine

Ed Shea

VP, Business Development

• 25 years of bio-pharmaceutical experience in commercial development, marketing and sales.

• 15+ years with Glaxo SmithKline in business development, sales, marketing, training and various leadership

positions. Therapeutic focus in immunology and infectious diseases.

• Regional Sales Manager with Salix Pharmaceuticals. Therapeutic focus in gastroenterology.

• Senior Director of Business Development with two startup biopharmaceutical companies, Critical

Therapeutics, Inc. and ViroPharma, Inc. Therapeutic focus in immunology.

• Holds a B.S. and an M.B.A. in Business/Marketing from Salve Regina University in Newport, RI.

Page 7: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

Medical & Scientific Advisory Team

7

Team Background

Dr. Peter Sheehan, M.D.

Advisor, Medical Director

• American Diabetes Association:

• Current President, NYC Leadership Council

• Current Chairman of Cardiometabolic Risk Initiative

• Former national Board Member

• Internationally respected Endocrinologist and diabetes specialist

• Clinical interest in peripheral artery disease, diabetic neuropathy, wound healing

Hana Chen-Walden, M.D.

Chief Medical Director

• Specialist in regulatory affairs in the pharmaceutical industry in U.S. and Europe

• 30 years of regulatory experience with the EMEA and in individual European countries

• Consultant since 2004 for European Clinical and Regulatory Consultancy

• M.D. from University of Tel Aviv, Israel

Yael Bobruff, Ph. D

Clinical Trials Advisor

• Post-Doc at Harvard University Medical School, Department of Systems Biology

• Extensive experience in Research. Lab work, Experimental design, project management, scientific

writing.

• PhD from Stanford University in Molecular biology and Genetics

• MSc from Stanford University in Environmental Engineering

• Graduated from Hebrew university with a bachelor degree in Biology with an added specialized

program in microbiology

Shih-Chun David Liu, Ph.D.

Scientific Advisor

• Research contributed to the fundamental understanding of the red blood cell membrane

architecture and identified surface receptor for malaria invasion

• Published over sixty research papers in prestigious journals

• Former research scientist in the Biomedical Research Department at Tufts Medical School

• Associate Professor of Medicine, Tufts University School of Medicine since 1992

• Ph.D. in biochemistry from Carnegie-Mellon University

• VP, founder at HDM Systems Corp., a green power electronic devices developer

Page 8: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

Diabetes Trend: A Growing Epidemic

8

US Population with Diagnosed Diabetes Diabetes Facts (US)

• 25.8 million people with diabetes (8.3% of U.S.

population)

– 460% increase since 1980

• 79 million people considered pre-diabetic

• 1 of 3 US adults will have diabetes by 2050 if

current trends continue

• Leading cause of:

– kidney failure

– non-traumatic lower-limb amputations

– new cases of blindness

• Major cause of heart disease and stroke

• $245 Billion in Direct and Indirect Cost to US

Economy

Source: CDC Division of Diabetes Translation. National Diabetes Surveillance System and 2011 CDC Diabetes Fact Sheet

0.00

5.00

10.00

15.00

20.00

25.00

30.00

1980

1983

1986

1989

1992

199

5

1998

2001

2004

2007

2010

People withDiabetes(millions)

% withDiabetes

Page 9: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

Diabetes Growth Projections 2012-2030

9

Source: International Diabetes Federation Diabetes Atlas 5th Edition: 2012 Update

38.4

51.2

33%

26.4

40.0

51%

55.0

64.2

17%

34.2

59.7

75%

14.9

28.0

88%

70.3

120.9

72%

132.2

187.9

42%

2012 : 371M

2030 : 552M

Increase 49%

World

Diabetes worldwide drug market size $35 billionExpected to grow to $58 billion by 2018

Page 10: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

Drug Product Pipeline

10

Product Description Indication Preclinical Phase l Phase ll Phase lll

Chewable tablet taken prior to meals to manage post-meal sugar spike

Type 2 Diabetes

Injectable anti-necrosis drug

Lower-limb ischemia in diabetic patients

PAZ320

IPOXYN

• PAZ320 works non-systemically in the gastrointestinal tract limiting

side effects

• IPOXYN is an injectable anti-necrosis drug intended to treat

hypoxia, which is the lack of oxygen to living cells

Page 11: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

Diabetes Complications

11

Eyes(retinopathy)

Kidney

(nephropathy)

Brain and cerebral circulation

(cerebro-vascular disease)

Heart and coronary circulation

(coronary heart disease)

Peripheral nervous system

(neuropathy)

Diabetic foot

(ulceration and amputation)Lower limbs

(peripheral vascular

disease)Diabetes Atlas, 3rd edition.

International Diabetes Federation

Page 12: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

Post-meal Glucose in Diabetes

12

•A growing body of evidence suggests that reducing post-meal plasma

glucose excursions is as important, or perhaps more important for

achieving HbA1c goals.

•The relationship between hyperglycemia and cardiovascular disease is

complex with evidence suggesting that an acute increase of glycemia,

particularly after a meal, may have a direct detrimental effect on

cardiovascular disease.

•Targeting both post-meal plasma glucose and fasting plasma

glucose is an important strategy for achieving optimal glycemic control

International Diabetes Federation2011 Guideline for Management of Post-Meal Glucose in Diabetes

Page 13: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

PAZ320 is Unique

13

Are there any drugs available that

reduce my blood sugar spike after

meals by 40%, that are non-systemic

and have no serious side effects ??

Page 14: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

PAZ320

• Complex carbohydrate chemical

structure

• Chewable drug taken before meals

intended for improved glycemic control

in Type 2 diabetes

• Novel, non-systemic approach to

blood sugar management

• Strong safety profile

– No serious adverse events (SAE)

14

Typical mechanisms

involve interaction

with liver, kidney,

pancreas and cells

Most Diabetes Drugs

Systemic

Works in the

gastrointestinal tract

PAZ 320

Non-Systemic

PAZ320

Page 15: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

PAZ320: Mechanism of Action

15

Enzymes break down complex

carbohydrates into simple sugars

Without PAZ320

PAZ320 Inhibits enzymes that release

glucose from complex carbohydrates

Carbohydrate-hydrolyzing Enzyme Inhibitor (CHEI)

With PAZ320

EnzymesEnzymes

• Fast Glucose Release

from Carbohydrate Foods

• Unhealthy Glucose Spike

• Directed systemically

•Less Glucose Released from

Carbohydrate Foods

•Controlled Glucose Increase

• Directed solely on the

intestinal tract

PAZ320 (CHEI)

Consume

Carbohydrate

Foods

Goal: Reduction of Postmeal Glucose Elevation

Page 16: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

Phase II Trial Results

Published in AACE journal Endocrine PracticeJuly-August 2013 edition

• 45% patient response: 40% reduction in

postprandial glucose excursion

• No serious adverse events

• Sense of fullness was observed

• Works regardless of duration of diabetes

• Works regardless of other medications

• No significant hypoglycemia

• Mild GI effects

16

4000

8000

Control Meal 4 tablets

Responder Summary Average Area Under the Curve

(p-value: ANOVA Friedman 0.012)

Average AUC

Trial conducted at Dartmouth Medical Center

Page 17: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

PAZ320: Current and Planned Trials

17

Trial Type Status Patient Population Goals

Phase II Study

Dartmouth-Hitchcock

Medical Center, US

Completed

Data published in

Endocrine

Practice Q3 2013

• 21 people with Type 2

diabetes

• Currently using oral

agents or insulin

• Efficacy and safety

• In combination with oral anti-

diabetic medications and insulin

Phase 2b

Lisieux, France

Initiating • 24 people with Type 2

diabetes currently using

metformin

• Efficacy and safety

Phase 3

US, Europe, Hong

Kong, Korea and China

Planned

Collaboration with

US diabetes clinic

• 300 patients • Evaluation of the effects of

PAZ320 on glucose HbA1c ,

AUC in patients currently taking

metformin

Mechanism of Action

Validation

University of Minnesota

Initiated • To study and validate PAZ320

mechanism of inhibition of

carbohydrate hydrolyzing

enzymes

Page 18: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

IPOXYN

18

• Carbohydrate-based intravenous solution that may

potentially prevent necrosis, or cell death

• Treats ischemia, or lack of oxygen supply to living cells

• New chemical entity, not a biologic agent therefore strong

regulatory position compared to biologic competitors

• Prevent amputation associated with lower limb ischemia or

diabetic foot

• Contains oxygen rechargeable iron which

picks up oxygen in the lungs

• 5,000 times smaller than red blood cell (RBC)

• Requires no blood type matching IPOXYN

RBC

Necrosis: localized death of

living tissue.

Ischemia: deficient supply of

blood to a body part, leading to

necrosis

Page 19: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

IPOXYN: Market Opportunity

19

Facts and Figures

Global Addressable Market: $30 billion*

Indications in which necrosis occurs:

• Stroke is a leading cause of death in the US

• Over 800,000 people die in the US each year

from cardiovascular disease and strokes

Competitive Advantage

• No current drug available to treat

or prevent necrosis

• Ischemia currently treated by high

pressure (hyperbaric) chamber

• All oxygen therapeutic drugs have

failed in FDA trials

• IPOXYN is stable and does not

scavenge Nitric Oxide

• Stable at room temperature

• Stroke

• Heart Disease

• Trauma

• Anemia

• Kidney Failure

• Diabetic Foot

• Surgery

Source: Center for Disease Control and Prevention; *bcc Research

Page 20: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

Milestones

PAZ320 Phase 2a clinical trial results show significant 40% reduction in the elevation of post-meal blood sugars; no serious adverse events; initiated Phase 2b

Principal investigators published PAZ320 Phase 2a clinical trial results in Endocrine Practice,peer-reviewed journal

Submit IND questions to FDA

*Please note that the above illustration contains future projections of BTHE’s product development.

20

2013 Milestones Achieved

Product 2013 2014 2015 2016

PAZ320•

Initiate Phase 2b trial

in France

File IND

Initiate Phase 3

pivotal study

• Finalize Phase 3

clinical study

• New Drug

Application (NDA)

IPOXYN • •

Initiate pre-clinical

experiments

Short term toxicity

studies

Pre-IND meeting with

FDA

• IND application • First in human study

indication

Page 21: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

Key Statistics

• Ticker: OTCQB – BTHE

• Share Price*: $1.30

• 52-Week Range: $0.15 - $1.65

• Market Capitalization*: $48M

• Shares Outstanding: 37M

• Headquarters: Manchester, NH

* As of 11/04/13

21

Page 22: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

OTCQB:BTHE

Highlights

Key Investment Highlights:

• PAZ320 uniquely positioned to capture market share of$35B diabetes drug market; Phase 2 preliminary clinicaltrials completed

• IP portfolio places the Company ahead of the curve incarbohydrate technology development

• The necessary resources for success are in place;seasoned senior team, cash reserves, IP portfolio

• BTHE is significantly undervalued

22

Page 23: Teach-in Presentation November 6, 2013content.stockpr.com/acornmanagementpartners/db/Client+Documen… · • Former CFO for Galectin Therapeutics, Inc. (Nasdaq: GALT) and its predecessor

Teach-in Presentation

November 6, 2013

OTCQB: BTHE

www.bostonti.com

Boston Therapeutics, Inc. Anthony Squeglia, VP of Strategic Planning

Phone: 603-935-9799Email: [email protected]


Recommended